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A Study to Evaluate NT219 Alone and in Combination with ERBITUX® (Cetuximab) in Adults with Advanced Solid Tumors and Head and Neck Cancer
NCT04474470 · View on ClinicalTrials.gov ↗
Study Summary
This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or metastatic solid tumors.
Conditions Studied
Interventions
- DRUG NT219
- DRUG NT219 and ERBITUX® - Dose Escalation
- DRUG NT219 and ERBITUX® - Expansion
Study Locations (10)
California
- California Cancer Associates for Research and Excellence — Encinitas
- The Angeles Clinic and Research Institute — Los Angeles
- UCSD Moores Cancer Center — San Diego
Other
- Hadassah University Medical Center — Jerusalem
- Rabin Medical Center — Petah Tikva
- Sourasky Medical Center — Tel Aviv
District of Columbia
- MedStar Georgetown University Hospital — Washington D.C.
Illinois
- The University of Chicago and Biological Sciences — Chicago
Louisiana
- Ochsner Clinic Foundation — New Orleans
Oklahoma
- Stephenson Cancer Center — Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2020-09-03 |
| Est. Completion | 2024-05-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04474470
The ClinicalTrials.gov registry entry for NCT04474470 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TyrNovo, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions — of which NT219 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04474470 reports 10 study locations spanning 6 distinct geographic areas — top geographies include California, Other, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04474470 about?
NCT04474470 is a clinical study titled "A Study to Evaluate NT219 Alone and in Combination with ERBITUX® (Cetuximab) in Adults with Advanced Solid Tumors and Head and Neck Cancer". This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or ...
What is the current status of trial NCT04474470?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2020-09-03. Estimated completion is 2024-05-08.
What conditions does trial NCT04474470 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Solid Tumor, Adult, Metastatic Solid Tumor, Squamous Cell Carcinoma of Head and Neck, Colorectal Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04474470?
The interventions under investigation include: NT219 (DRUG), NT219 and ERBITUX® - Dose Escalation (DRUG), NT219 and ERBITUX® - Expansion (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04474470?
This trial is sponsored by TyrNovo, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04474470 being conducted?
This trial has 10 study locations across California, District of Columbia, Illinois, Louisiana, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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